try to supplement without grants and scholarship from the campus, we don't have enough. we don't really have enough. we've been going to what i usually call our grate and grateful alumni to be build up our portfolio to help people like your family to come to the university of illinois. this is something that we are doing. we are making sure that the increase in tuition is held at the inflation rate making sure that people can really afford school. it's a pity. i went to school and a four-year college after that. and i i know at that time, the institution rate was very, very low. but with the current state of the economy, the current state of the economy and decrease to a large extent in the state funding has been very, very critical to increase a little

bit of the institution to be able to maintain the excellence and teaching capability of our institutions. so, i main focus now is making sure that we raise funds for scholarship, for grants, and making sure that we bring your kids and my kids also to a great institution that prepares them for a life-long learning, life-long job and life-long citizenship in a great country. >> provost, here is a tweet from one of our viewers, lauren, who says virtual schools will be one tenth the cost. >> well, virtual schools are great for people who are very interested in that. but i believe sincerely in the residential experience for students. it's not -- i mean, it's not

only bringing the students here to study, but bringing students here to socialize, to create networks, to make friends, to meet people from all over the world. if you stay in your bedroom, that's very difficult, very, very difficult to produce what i call a whole citizen. we believe we produce online education for people who are desirable of that and we also use those to teach our students on campus so that they can have education any time they want in the day. but, eventually my belief and the belief here is that residential education is extremely important not for only the educational aspects but for the social development of young people to be able to partake of a democratic society. >> and here is another topic for you, that is the issue of free speech on college campuses and

civil discourse. here is a headline from "the guardian" a professor at the university of illinois was fired for israeli criticism and urges the university of illinois to reinstate this professor. what is the university of illinois's policy civil discourse and free speech? >> look, civil discourse and free speech are the lynch pin in this country's armor, in times of democracy. i think the professor in question was not fired, he was just not hired. and in our classrooms on campus, we go to the campus, you can talk to the students, there's no restriction whatsoever on free speech or academic freedom on our campus. and we are the chancellor and

myself, we are talking to faculty on campus, really debating, trying to get everybody to really start discussing, debating free speech and academic freedom in this new age. and we've been visiting colleges, we've talked to professors who thinks free speech is done, it's written in the first article and is done. but we talk to law professors who teach free speech for a whole semester and thinks maybe there may be limits, but these are subjects for discussion. and every new generation have to discus so that they can imbibe the lessons of what people fought for for a long time in this country. so free speech and academic freedom are alive and well on our campus and this is something that we're committed to, no police thoughts yet, no trying to limit any speech. our professors can challenge any

establishments in the classroom because we have to train our students. we just have to train the students so that when they get out of here being respectful of other people, being just engaging, we have a tremendous number of out of states students, foreign students, how do you become a global citizen? free speech and academic freedom is a part -- they are a part of this education. >> what about out of the classroom? are you monitoring your students and your faculty's twitter page, facebook, other social media? >> not at all. if we are doing that, it means that we have nothing to do on this campus. we don't monitor anything that our faculty are doing outside of the classroom. faculty, students, staff, they can do anything they want to do. they can say anything they want

to say. that's -- it's a great place to come, it's a destination for people who want to come here to come partake in the largest library collection in the world on any campus. so these are things that we take as a given on our campus. academic freedom, free speech are a core value, a core value of this institution as well as of course as of the country. >> then why was this professor not hired? >> well, i think -- the board of trustees and the chancellors have made their decision. i do not want to second guess, but i think we try to move on from that. encouraging our faculty and students to really come together and initiate discussion.

there are many university of california in burkely, yale university, these are hot topics right now being discussed and we want to be in the middle of that. in the decisions of ak semiic freedom and free speech. i will say that the board of trustees and the chancellor made the decision to not hire the person in question, but now it is for us to really talk amongst ourselves and nationally this particular issue. >> okay. we'll go to lavella in illinois. go ahead. >> caller: hi. my name is lavella and i'm really happy to be able to get you guys. i've been trying since 2006 or '7. and my question is pertaining to children of military families, active duty and retired. can you hear me? >> we can, lavella. so what is your question? >> caller: okay. my sque, my daughter is active

duty military and she has a stepson and also has two younger children. so, does she qualify for any kind of assistance for her stepson? this is their home state of residence because she plans to use her other benefits for her two younger children. can she use the benefits for all three? >> well, i don't know the exact what is it called -- i do not know the exact conditions under which they operate, but what i say is that this is a very, very friendly institution to the families of veterans. i'm sure we have programs on campus that cater to veterans and their families. one thing i will like to say, it's a destination for wounded veterans. we are presently building a center for wounded veterans in higher education. that's coming up. education and research issues for us. when you look at the history of

the university of illinois, a lot of standouts, all those were invented here or developed here at the university of illinois. so, this is an institution that has catered to veterans and their families for a long time. actually since the beginning or end of the second world war. we have been a destination for veterans of false tribes. so i look over at what you've said and maybe you can call our veterans' office to really seek out if you let me know your number, i will talk to our veterans office and i can call you and give you the information on that. so i will be waiting for the call after we leave this place here. >> okay. we'll go on to rob who is an educator in south burlington. go ahead, rob. >> caller: thank you very much. i think one thing that we're not

really kind of addressing in this discussion is how broken the model of traditional higher education is. the financial arrangements, which are heavily dependent upon student loans, and also adjunct faculty salaries is just unattenable. you can't expect people to pay, 20, 30, $40,000 a year on education and have that education be valued when the first two years are in incredibly large classes, where they're -- the debt that families are having to take are so large and it's really important to recognize that there are a whole bunch of other kinds of businesses and institutions that are kind of stepping in, they can check out a player you can check out courses -- why aren't the university of illinois or most

schools accepting the ♪ for introductory classes. introductory classes are taught by adjuncts who get paid very little money. >> how many students are in one of those entry-level classes, economics 101 taught by adjunct professors? >> well, we take pride in our institution that many of our introductory classes are actually taught by professors in the classroom. that is something we take pride in. we have an on going right now campus conversations on graduate education. we are re-imagining, rethinking how we teach our students. so you can check it out. anybody can check it out that our students and our commitment on our campus is that many of

the first-year -- probably all of the first-year education is provided by professors. we may have adjunct we don't call them adjunct here, we call them specialized faculty. we want to develop great professional tracts for those individuals if they choose to remain on our campus for a long time. so we are -- i don't know about other schools, but this is something that we are committed to, okay? the model for higher education, the caller said is broken. i don't know whether it's broken, but what i can say is that we are partner of the cosara company. we use them for outsiders and also for our students in terms

of free classrooms. students taking those -- listening to those lectures and then coming to class to ask questions. so these are -- we are looking at other model possible to make sure that we can deliver education at the lowest cost possibly in this particular economy. >> jim is next in robinson, illinois, parent there. go ahead, jim. >> caller: yeah. my son -- >> may i add one more -- may i add one more thing is that the student/faculty ratio at our campus is 19-1. student/faculty ratio is 19-1. we take pride in that making sure we touch the students who come to our campus. >> let's hear from jim. >> my son is a senior in high school. we're about two hours south of champaign and it's a land grant college for illinois. and our schools it seems like

our kids somehow kind of are less of a disadvantage, like they don't push math and science enough so they meet the entrance exams for say a big ten school, university of illinois. for a lot of people down here in the farm belt would really like their kids to go because we're like fifth generation farmers down here, and i just wanted to know is there some kind of program that gets kids if their families have lived in illinois all their lives kind of help to get them in there, you know, so many people around here say, well, if you're not from a foreign country or something like that where your math and science is good, you can't go to the university of illinois. >> okay. >> well, we are working with actually teachers from local schools to really start improving the standards, giving them more ammunition in terms of teaching students. and one thing that we're looking

at and we're on our way to implementing them is using a mook platform to start partnering with high schools that do not have teachers in math or physics or chemistry or things in that area. so that we can start engaging the local families and local schools, preparing the students to be able to partake of the education at this institution. so that's something that we are looking at very, very seriously because in the farmland, we want to make sure that the opportunities is flat, we're provide a flat grant -- we provide a flat environment for students from any area or any financial background or academic strata to be able to come to university of illinois. so that's something you may actually see some of our faculty tor college of education come into the area and talking to teachers in high school.

>> we're running out of time here. the house of representatives is about to come in for their morning session. so let me go to a tweet, if i could, real fast. this is from one of your viewers who wants to know how large is the international student body, according to the campus paper, they put together this graphic, this map that shows there's 658 students from china, 132 from india, 126 from south korea. singapore, 21 students and taiwan, 18 students. why is there this international presence at the university of illinois? >> yes. >> well, the university of illinois over the last 100 years actually we have a rep putable history of engaging international students. if you go to china, i've been there, to a university there, actually you find out the campus is modelled after the university of illinois urbana-champaign.

we trained the first architects in china at this university. you can find that i was an international student once. i came and i stayed and i believe many international students come and stay in this country. because of the opportunities. and we have over 5,000 freshman from the state of illinois. those are first stake holders. we have a lot of students of illinois over the last many years we have grown and we have taken out of state, not only international states but students from california we have a lot of students from california, new jersey and from around the country. so this is an international environment. we always say that our students can do study abroad, illinois students can do study abroad on campus. we are very proud that we have a global reputation. >> and i apologize, mr. adesida.

we have to leave it there. we continue with indiana university president michael mcrobbie. >> this morning, the c-span bus is on the campus of indiana university in bloomington. on it, we are joined by the president of indiana university, michael mcrobbie. thank you very joining us. >> delighted to be here and welcome to indiana university. >> thank you for the invitation. can we start, president, with your general thoughts before we talk about the details of your university, but your thoughts on the greatest challenges facing those in higher education today? >> oh, i would say that probably

the greatest challenge in front of us is to continue to provide a quality and affordable education, especially to the students within the state of indiana. we are a state university, after all. and keeping that education both affordable but also ensuring its quality so that our students are graduating with very high level skills that will enable them to prosper in the workplace, i think is one of the greatest challenges. of course that involves a whole range of factors to do with the sources of funding for an institution with a budget of $3.3 billion. >> so what steps do you think have to take place in order to balance that affordability with quality? >> well, i think one of the key things that we are doing in

terms of affordability is we have really focussed in lazer-like in the last couple of years on the whole issue of student debt. you're probably aware that this has got -- i'm sure you're aware that this has got enormous and appropriate national attention. and it has been a concern of ours. and so, last year we introduced a comprehensive financial lit r littersy program that involves things like modules that all entering freshman have to complete on financial littersy, courses on financial litsy. gives students much better control and knowledge of their student debt. and what is remarkable about this is that we saw 11% drop in the amount of debt that students took on this year. and that amounted to $31

million. and what i think is remarkable about that is that if you multiplied that across all the institutions of higher education in the country and there are 4,500 of those, if you multiplied that, you could see how one could have an enormous impact on the amount of the student debt that students are taking on. of course, debt is a critical opponent of affordability. can one actually find the resources to fund an education. so that has been a really major program that we have been focussing on, aimed at affordability of an ininn university education. >> so on the larger aspect, president mcrobbie, if college was worth it, if they asked you that, how would you answer? >> well, i don't think there's any doubt that college is worth it. study after study after study

shows that your prospects in the workplace in general are better with a college degree than without a college degree. now, it certainly is the case that there is a growing emphasis on the kinds of skills that students are graduating with. and we have put in place -- in fact, i announced this last year that i asked all of our schools to comprehensively evaluate opportunities for creative degrees of certificates, associates qualifications, maesers degree and so on. and just last week we announced a new program between our very highly ranked school of business and a college of arts and sciences that will provide an accelerated bachelor plus masters degree that will provide

a bachelor's degree in a field like economics, mathematics and so on and one-year masters degree in business. so that's an accelerated process and that one-year masters degree can be completely completed online. so you can see how students in a number of different fields can graduate, go into the workplace and then complete another masters -- complete a masters degree online in obviously a very practical applied area of business, which is a skill that is always going to be sellable and marketing by our students. so we're looking at initiatives like that across the board. we have a program already that provides certificate of business on top of writing different bachelors degrees as well. and we are very mindful and i think we have a responsibility

to our students to be concerned about their welfare after they graduate. i mean, we simply cannot as an institution complete a student's education and waive them good-bye and not be concerned about what happens to them then. so the programs i've described to you are really focussed in part on responding to the need for greater schools to go along with the classic kind of liberal arts education that we provide at indiana university and we're also mindful of the fact that inspite of the fact that unemployment is still relatively high, though falling, there are by some estimates 2 or 3 million unfilled positions because not enough graduates are graduating with the right kinds of skills. all of that is what we're focussed on. the final part of that is a comprehensive approach across the university to really improve

career consulting, career advising, sorry. we're really focussed on ensuring that all of our students have access to top quality career advising to help to maximize their stunts to find employment once they graduate. >> c-span bus is doing a big ten college tour. presidents are joining us on the bus to talk about issues of higher education. we're joined by the head of indiana university, michael mcrobbie. you may specifically gone to the school or have questions generally on the issue of higher education. here is your chance to talk to him about. students, 202-585-3880. for parents 202-585-3881. perhaps you're an educated at a university, 202-585-3882. about 46,000 students at the indiana university in bloomington. 36,000 of those so are

undergraduate. 10,000 undergraduate and faculty and staff of 8,300. when you talk about cost of college specifically for indiana university, how much of your cost is taken up by employee salaries, staff salaries and facilities? >> oh, personnel salaries are the largest single component of the cost of the university. it would be around 80% of the total cost of the university, personnel related salaries, plus benefits and health care and so on. we are a personnel intensive organization, like most other universities there. so, we are very much focussed on that direct interaction between students and instructors in the classroom. and although i think we're seeing a greater and greater impact of online education, i

still don't think there's an enormous amount of evidence that it's going to completely replace that fundamental student/teacher relationship which has existed for as long as universities have existed which is over 25 centuries. >> the annual budget for the indiana university, 1.4 billion, endowment of $2 pl in alumni approximately 370,000 worldwide as far as your annual budget is concerned, you talked about personnel. what about facilities? how much do you have to spend to keep up facilities and add facilities? >> well, this is actually been -- this is my eighth year as president. and this has been a major focus of our board of trustees over this period. like many institutions, i'm afraid we actually had a very large deferred maintenance bill. this is the kind of stuff that's not glamorous. it's the roads and sidewalks,

the steam tunnels, et cetera. but there's a rule in business that every dollar that you don't spend now you're going to have to spend $4 in the future to rectify that. so, we've been putting over the last seven or odd years or so an enormous amount of effort into trying to at that level catch up with the significant burden of deferred maintenance and more recently we've had just excellent support from the state. now, on top of that, we're also looking at renovating major buildings on the campus and bringing them up to the kinds of standards and to provide the kinds of facilities that are required to support the type of research of the 21st century university. over the last seven years, we have constructed or have under construction at the moment or in planning over 50 major facilities. and we have spent about -- this

is cost about $1.5 billion. what's interesting about that is that only 30% of that has come from the state. the other 70% has come from a whole variety of other areas including considerable amount of individual philanthropy. >> 202-585-3880 for students. 202-585-3880 for educators. let's start from ann from dayton, ohio, who is a parent. good morning, ann. >> caller: that's a beautiful campus and beautiful town, bloomington, but i want to talk about my direct experience as a single parent with three daughters and not much economic help with my ex. i have encouraged my three daughters all in their 30s to be excellent students and that that was their job. and they did. and i was middle income. and they qualified for great scholarships at small private schools, my oldest went to ober

lin and i only ended up having to pay 4,000 a year there. and then the other one got into lie owe la, they all got into small private schools. and what we experienced -- the youngest decided to go to the university of colorado and they didn't give a great package. and we found out that after her first year, you know, and we went into debt for that first year, that we ran into a lot of extremely wealthy kids who were lying about being in-state status at a large school and then getting instate pay, which she did get after jumping through all the hoops of living in stas after her freshman year for a year. so, do you have that same kind of thing where wealthy kids are claiming to be in state, actually getting money from parents, which happened at the university of colorado big time. so talk about small schools and giving, i believe, better

scholarships and big funding than large state schools and i hope c-span goes and visits some of the small, private schools. so if you could address that issue, thanks. >> ann, thank you. president mcrobbie, go ahead. >> yes. firstly, let me say that we take very seriously and are acquired to by the state the distinction between in-state students and out of state students and we have pretty rigorous requirements for what the requirements are for a student to be regarded as an in-state rate. we have committees that deal with appeals and requests to be considered as in-state on a regular basis. but they are very hard-nosed about what the criteria are and we sort of pride ourselves on applying them consistently across the whole university all

campuses. now, with respect to financial aid and scholarships and so on that you were talking about, i mean, we're a very large university. we have on this campus over 46,000 students. but -- and 36,000 undergraduates, but we also pride ourselves on the fact that the students with average family -- in-state students with average family incomes of 50,000, they pay almost no tuition because the combination of state, federal and university based financial aid pretty much covers the total cost of their tuition. then students of family incomes of 100,000 or less, they pay somewhere in the vicinity of about half the total cost of tuition again because of all the different sources of financial aid that are available to them. in fact, at iu on this campus, about two thirds of our students get some form of financial aid. it was a major focus of our last

two campaigns. it will be a major focus of our upcoming campaign. in our last campaign for our bloomington campus, we raised over $200 million. if you include graduate scholarships probably close to $300 million in support of scholarships, fellowships and so on for undergraduate students of both need and ability to come to indiana university bloomington. >> so president mcrobbie, what qualifications do you look at in accepting potential students? >> oh, firstly we look at obviously the kind of things that all institutions do, sats or acts, their gpa at school, class ranking, what other extracurricular activities that they have engaged in. but we also use what we call holistic evaluation. that is, on the whole, most

students a decision is relatively easy to make, yes or no. there's still a significant number of students who fall somewhere in the middle where you want to actually take into account everything about that student, maybe their gpa is not that great but if you look at their gpa, it started low in their freshman year at high school but by the time they got to their senior year it improved so there's clearly some sign of maturity or maybe an extracurricular activities they've been major leaders or innovators at their high school. so we want to take all of that into account and as a large state public institution that we really are doing all that we can to identity and find those students who we think will prosper at indiana university. >> what about students who may need some remedial help once they enter the university, what kind of assistance are they

offered? >> well, in indiana, as a state, most of the remediation is actually carried out by a community college system. so, we actually on this campus provide very little remediation anymore and that is actually provided externally. and we find that our students on the whole arrive pretty well qualified for the courses of study that they are intending to undertake. and if they need remediation, they take that in one of the community college campuses of which there are in excess of 20 around the state. >> how many of your students are taking humanities classes or social science majors versus professional and technical majors, what's the breakdown? >> i don't have the exact figure in my head, pedro, but i think in our college of arts and sciences probably something like a third of the students there are taking courses in the

humanities and social sciences. we actually are a university that is very strong in the humanities and in the social sciences with some very highly ranked departments in those areas. and i showed this is probably an opportunity to add to that that languages has been an area that we've been particularly strong on. we teach in any one year we teach somewhere between 70 and 80 different foreign languages which is probably makes us in terms of the number of languages toward one of the top institutions in the country. there are a few other universities that teach that many foreign languages. we teach foreign languages in just about every part of the world, the commonly taught ones but also a lot of the less commonly taught ones as well. we also teach the culture and politics, economics, history and so far, we have series of title

6 centers that cover the whole of the world as well. but we decided that we needed to bring all that together to try to increase the kinds of educational opportunities that we provide for our students. so, now about two years ago, our board of trustees approved the formation of a new school of global and international studies. and your colleagues will no doubt see the very large building that we're building at the moment that will house the whole of that new school. and that school will house language programs in about 70 to 80 foreign languages and all the associated programs in this culture of those particular culture, history, economics, et cetera. those particular regions of country. and we appointed a new dean of foundation dean for the school last year. and he's just commenced his

position here. he's a former u.s. ambassador to poland and has worked in the white house and elsewhere in washington. so, our goal frankly in that area is really to become one of the top international study schools in the midwest. consequently provide not only specialists qualifications in international studies but to expand and enhance the kinds of majors that we can provide to our students, because in my view, it's certainly been a priority of mine and the university and our trustees, one of the most important things that we have to provide as a university is international litt litteracy. a parent, hello. >> caller: hi, how are you doing? my question is regarding the endowment. you see the endowment at 800 plus million dollars. what is it used for?

my second question, i see a lot of date rape and alcohol use on campus? what is the university doing about that? i'll take it offline. thanks. >> let me deal with the second part of your question first. there is nothing more important to us as a university than the welfare of our students. i mean, we are obviously deeply concerned about the welfare of all of our students. so, earlier this year we announced a student welfare initiative, which is a comprehensive approach to problems of sexual violence and the other kinds of issues that you have raised across the institution that is actually managed and administrated at the very highest level in the institution. two vice presidents co-chair an executive council that is

actually responsibility for both the comprehensive evaluation of our present policies, their improvement and the implementation policies in this area. one of the things we're most proud of on this campus the bloomington campus on the university of indiana, is the fact that our students were not just sitting around waiting for the administration to do more to address these issues and so on. our students a number of years ago formed an initiative called cultural care, which is a student-led initiative that is completely run, managed and initiated by our students which is focussed on students helping students bystander intervention, bystander awareness and so on and as well. this is something that i have nothing but praise for the work of our students to put this program in place. and it has had a significant

impact. and i know it's been widely praised and looked at by other institutions. now, returning to the first part of you question, the total endowment of the university is across all campuses is $1.8 billion. i should note that we're very proud of this. this pails compares to harvard who has a total endowment of $35 billion. but the $1.8 billion endowment that we have goes to a variety of different purposes and those are defined by the donors. for example, i'm a donor to the institution. my wife and i support four different graduate fellowships there and those graduate fellowships are defined by a formal legal agreement between me and our university foundation that's responsible for this and that's true of tens of thousands if not hundreds of thousands of other people. although it sounds like a large amount of money, the great bulk

of it is all identified for specific purposes. undergraduate scholarships, graduate fellowships, endowed professor ships. funding to support research programming and the very schools within the university and some of it to support the building and construction of new infrastructure. >> our guests joining us on the c-span bus as it continues to visit big ten schools, michael mcrobbie, the president of indiana university, a native of australia and how did you end up the president? >> how did you know i was a native of australia? i was recruited here -- i'm a computer scientist by background. i was recruited here now over 18 years ago and i came here as a vice president for information technology and computer scientist and i then became vice

president for research and provost and i was appointed president. i never expected when i moved here that i would end up president of the university but i'm very honored and delighted to be in this position. and i must say, as much as i enjoy visiting my home country, i'm an american citizen now. i never regretted the move for one nano-second. this is home. indiana, bloomington, wonderful place. indiana university is a fabulous university. and i enjoy every minute of my life here. >> let's hear from lauren from pennsylvania, an educators, hi, lawrence. >> caller: hi. president mcrobbie, i would like to get into your general education program. and i would like to know kind of a followup to an earlier comment on what kind of humanities, philosophy, history, english a student -- well, all students are likely to get in those

important first two years of college. thank you very much. >> yes. we have a general education program that with some variations applies all cross all of the campuses across the university, all seven campuses on the university. on this campus in particular, bearing in mind it's a large campus with many different courses, many areas, in summary, students are expected to have done a series of consecutive courses in the humanities, social sciences, natural sciences, mathematics, and also to have done a number of years of a foreign language. and this was put in place by our faculty through their initiative now about eight or nine years ago. and has recently commenced and

it is a program and the general concept of general education is something that has my complete support. it is, to me, one of the real fundamentals of american higher education, that is what's called liberal education. so you get an education in both brit of the different areas of human knowledge but you also get an education in certain areas the areas which you major or minor, you get an education in some depth. and that model, the american model of liberal education, is frankly the best in the world. and i speak of somebody who comes from another part of the world and seen a lot of other systems around the world, it is one of the most envied things about the united states is the quality of education, the liberal education that you get at an american university.

i'll give you another example. i was in china now maybe five years ago meeting with some chinese university presidents and they told me, you know, we have studied your system of education and we have poured money into higher education in china and we're still not getting the right kind of graduate who is so creative and innovative as the kinds of graduates that come out of american universities and we've studied your system and we believe that the key thing that we're missing is the system of liberal education that you have in the united states. and so you'll now see that some of the major chinese universities are developing that kind of an approach because of what they see as the enormous success that this system has had in the united states. >> 202-585-3880 for students. for parents 202-585-3881 for

educators, 202-585-3882. >> i'm sure you've heard the argument that you should go to college, get an education that will guarantee you a job. >> well, i would go back pedro, to what i said before about the fact that we're certainly aware of that concern. and as i indicated and gave an example of a major new initiative in the university that we just recently announced which provides both a bachelor's degree of the classic kind that i was just describing with a one-year masters degree in business and provides it on an accelerated basis, normally that would take six years or so and we provide this in five years and also provide the opportunity for that last year to be online. and that's in direct response to that concern, which i think in some cases is a legitimate one.

as i also said, we are -- have already looked at and are looking at expanding that across all of our schools. so, for example, our school of mathematics and computing is in the process of developing this same kinds of accelerated bachelors degrees plus masters degrees and so on that provides somebody with a qualification in inframatics and computing on top of a bachelor's degree of a more classic kind. we're very much aware of that, as i said. but we think that there are enormous benefits of the classic liberal education, the kind i was just describing, but then when coupled with an additional qualification, business and so on really well positions and well qualifies a student to be successful in the workplace.

>> what competition does the university get from for-propefi universities? >> i don't see very much competition at all, frankly, from for profits. very little. i think our major competition is from the rest of the big ten. all my colleagues you're visiting around the midwest. we all compete among ourselves in general and very healthy way for the best students and the best faculty. i mean, the universities you're visiting are in some ways i think one of the real unharolded strengths of this country. people may think more of the west coast than the east coast, but the big ten universities that you're visiting of which of course there are now 14, but the big ten universities that you are visiting, collectively, do an enormous percentage of all of the research, enormous

percentage of the graduate students, ph.d. students in the united states, something of which in the big ten we're very proud. >> what do you think of the quality of for-profit universities? >> >> i didn't catch that. >> what do you think about the quality of for-profit universities? >> i would leave that to others. there has been controversy about that question. i think the key thing as i said is we see -- we see -- for-profit, you're not talking private institutions, which are not for-profits but different to a public university. but we see very little competition from them. >> lou from virginia beach, a parent. >> caller: how are you doing? >> go ahead. >> caller: i'm trying to ask the question that -- about he explained -- mr. mcrobbie explained about being a liberal education.

how does he mean liberal? what does he mean by liberal? hopefully, it's basically in english. basically he's teaching the foreign languages for basically understanding but not teaching in those foreign languages. >> we will let our guest respond. >> yes. i quite often have to say when i talk about a liberal education, i do not mean in the political sense. i mean in the classic sense of both breadth and depth in an education. that's what i mean by that. that does involve, as i said in response to one of the other questioners, being able to have done courses in indicative areas of great breadth of human

knowledge. the humanities, the natural sciences, the biological sciences, the mathematical sciences. >> mr. president, a question about academics from twitter saying -- a viewer asking, should college athletes be paid beyond a scholarship for bringing in millions to the university budget? >> i think that -- this is an area where we really have responded vigorously. i would like to think we have become a national leader. earlier this year, we announced our student athlete bill of rights. there's some very fundamental new innovations in that student athlete bill of rights. firstly, we will cover the full cost of attendance for our of our student athletes. everything that's involved in their education is covered through the scholarships we provide.

more importantly, we are now going to provide full four-year scholarships. as a student comes -- a student athlete comes to our u and starts and even if for performance reasons, other reasons they are no longer competing in athletics, we will guarantee them a scholarship for the four years. it removes from -- the concern -- any worries about the future of their education. then on top of that, we're also mindful that for reasons sometimes the family related, sometimes other reasons, a student may leave before they graduate. we will guarantee that at some point in the future that that student that we will then cover the remaining cost of that student's education, assuming they're in good economic standing. you think about that. a student comes to our u. he or she has been a fantastic athlete.

after two years they get recruited to go into the professionals in whatever their sport is. they don't finish their degree. they break their leg. they can never play again. what are they left with? probably very little. we will guarantee the cost of their education back at indiana university to finish their degree so they now have a chance to kind of re-establish themselves in another profession with that indiana university qualification. there's a series of other major components to our student athlete bill of rights. there are ten major components to it. it's very much focused on a really comprehensive approach to improving all aspects of our engagement with student athletes at the university. >> mr. president, what do you see as the future of the university, not just yours, but universities as whole? what do they face as the future continues? >> well, i have had a particular interest in the history of universities.

i'm fond of saying that with the exception probably of the catholic church, universities are the longest lived human institutions on the face of the planet. there's a university in china that claims to have been founded in 200 b.c. so it's older than the catholic church. look at the history of some of the great universities in india and so on. they existed for a thousand years before they came to an end. universities really have the seeds of being very long lived within them. that doesn't mean that there aren't fundamental changes coming in terms of already here, in terms of the model of education that we provide. i'm an information technologist. i have seen the impact for 40-odd years of my career. information technology is having a major affect.

but it has had a major affect for the last 40 years. to me, that affect is more incremental. i'm not somebody that believes it's going to collapse tomorrow and become a new model. i think it's going to change. i think it's going to keep changing. the chairman of our board says that all university administrators should make up scared every day about where the changes might go. but i think so far what we're seeing is incremental but constant change as opposed to complete paradigm change within the institution. >> if you had to look at one thing you would say universities have to do to stay competitive, what would that be? >> well, i think clearly where we started the interview, they have to remain affordable.

i give an example of that the fact that we, last year, had our lowest ever -- at least for 40 years -- tuition increase. we're focused on keeping education affordable. the other thing is is that we also at the same time have to be able to compete for the very best intellectual talent out there. if by universities you mean american universities, it's a white hot competition for the very best intellectual talent out there. we compete now -- i have seen this happen in recent years. very good faculty from asia, europe who probably would not have considered going back to their home countries ten years ago who have returned to their home countries because they have got better offers there. that's the very best faculty

doing the best research and the great teachers. it's these people who are really fundamental to our institution in both retaining them and recruiting them to us is a critical part of what we do. >> let's hear from kathy, an indiana resident. if you can jump right in with your question, go ahead. >> caller: yes, sir. i'm a cosigner for all of my daughter's student loans. she's a graduate from iu. it's crippling to our family what's happening to us. i've been served over seven times from the sheriff's office, we have been late on student loans. what can be done about this? we signed up for the scholarship. we did everything that was supposed to be done. when it was time to go to college, it fell through. her american dream is not realistic. she will never get married, by a home. we are so far in debt.

the job she has now has nothing to do with her college degree. she doesn't even need a degree for it. we're sunk. >> i think that the kind of story you tell is, i'm afraid, all too common. we have very much focused on trying to reduce that kind of problem in the future. that was, i think earlier in the interview, what i described was a comprehensive approach to financial literacy at indiana university. an approach that both educates students in personal financial management. it actually educates them in the consequences of taking loans. it helps to educate them in understanding what they really need money for as opposed to

just being given what's the equivalent of a credit card with a big limit on it. we are aware of the fact that a lot of students are getting loans beyond what they need for their education. getting a handle on and managing student debt again is one of the most important things that we're doing as an institution. i think the impact of this, as i indicated before, 11% reduction in the amount of -- the amount of money borrowed by indiana university students last year, $31 million reduction is at least the beginning of a way of reducing the kinds of problems that you have just described. all of what i described is in place or continued to be in place. we will enhance and build it. i expect us to see a continued decrease in the amount of

student debt at the university combined with an increasing amount of funding for scholarships, fellowships, student financial aid, coming through things like campaigns in the institution. it will be a major focus of our next campaign which we'll be announcing shortly. >> mr. president, what do you do to keep in touch with the student body? how often do you meet with the student body directly? >> i spent -- i spent probably three hours last -- just last friday afternoon with a group of student advisers to the president. we have had this group now for nearly 100 years. i meet with them on a regular basis. it's one group i meet with. later today, i have lunch with all of the student leaders on this campus. so i'm probably interacting on a

weekly basis with student leadership in some form. i have a number of student interns who work in my office. but i should add that, we are a very large institution. we have seven campuses across the state. with 115,000 students in total for indiana university. comprehensively keeping in touch with all of them is obviously going to be difficult. but i certainly think i get a good sense of the feel from the student body. i have to say that the kind of work that has come out of our students -- i mentioned the culture of care initiative before. the group -- the adviser group i talked about. they provide me with annual reports on different areas that we agree on. the quality of work that comes out of our students is good as

any work coming out of any faculty. >> we will have to leave this conversation with you. michael mcrobbie of indiana university, the president joining us. thank you. >> saturday on washington journal fellows from george mason university and urban institute discuss gop plans for the economy laid out earlier this week in a speech by house speaker john boehner. and gordon adams talks about isis and the middle east and ukraine and deteriorating relations with rush. dammon williams from the boys and girls clubs of america discusses the challenges facing american's youth. they will also take your calls and you can join the conversation on facebook and twitter. washington journal begins live at 7:00 a.m. eastern.

next a house subcommittee health hearing on the challenges of antibiotic resistance. i want comes as the president signed an executive order on thursday creating a task force and ordering the government to create a national plan on how to fight such infections and illnesses. dr. janet woodcock director of the fda center for drug evaluation and research was among the witnesses at this hearing chaired by congressman joe pitts. >> they are here, i'll yield. >> the subcommittee will come to order. chair will recognize himself for an opening statement. according to the world health organization's anti-microbial

resistance global report on surveillance 2014, anti-microbial resistance, amr is an increasingly serious threat to global public health. british prime minister david cameron warned in july that if we do not confront the threat of antibiotic resistance we could be, quote, cast back into the dark ages of medicine where treatable infections and injuries will kill once again, end quote. in just yesterday, the president announced an executive order focused on efforts his administration plans to take with regards to the antibiotic resistance issue. in 2012, this committee sought to help combat this global threat bypassing the gain act as part of the food and drug

administration safety and innovation act of 2012. it was the first step in the fight against antibiotic resistance and a great example how bipartisan collaboration on this committee can save lives. and i want to commend the bipartisan authors that made gain possible, including representatives gingrey, green, shimkus for their leadership. i want to commend the fda for its role in making gain a success since its passage but what is clear to many in this room is that gain did not fully fix the problem, and much more is needed if we are to incentivize the type of drug development needed to combat this global threat and to that end congressman gingrey and green have introduced another piece of legislation, the adapt

act which would seek to address problems related to fda approval process of antibiotic drugs. it is one of a series of proposals that warrants serious consideration by this committee as part of our 21st century cures and i want to thank them for their continued efforts in this space. i would like to thank all of our witnesses for being here today, and yield the remainder of my time to the vice chair of the subcommittee dr. burgess. >> thank you, mr. chairman and certainly appreciate the fact we're having this hearing today. it's necessary as we proceed with cures initiative to talk about some of the things that are important and relied upon in our ability to fight infections. antibiotic resistance specifically resistant strains is a growing problem equally troubling despite widespread supersport a lack of a pipeline of new drugs that can improve on

previous generations or fight drug resistant strains. a lot of facets to this issue and there's no single silver bullet solution. but here's the deal. our drug arsenal is our drug arsenal. today the committee continues to probe the various market reasons why we're not producing new antibiotics and if the proper market incentives and regulatory pathways exist to encourage the development of new drugs. important strides have been made in fda safety and innovation act most notably through the gain act but they were the first steps. part of the deal is once nature adapts it's hard to force nature to unadapt. these resistant strains are out there and they aren't going away. once this evolutionary leap takes place we're not going back and that's why we need a continuous pipeline of new drugs. i would point out on a historical note, since the election in scotland was yesterday and scotland will

remain part of the british empire of course a famous scotsman that's credited with the discovery of penicillin. but sir alexander fleming, the is only come he couldn't produce a lot of penicillin. and it was andrew moyer, from indiana, who actually develop the deep fermentation process that allowed penicillin to be mass-produced and really made a significant difference in the lives of our soldiers, or the saving of lives of our soldiers returning from world war ii, and parenthetically dropped the cost of penicillin from $20 at that time, a significant amount of money, to less than 50 cents. we know we can do this, and we know we should do this. we have done it before. the forefront of innovation and that's what the gain initiative is all about and i think that's

an important part of our discussion. but i will submit this article on andrew moyer for the record. >> without objection. you'll be entered into the record. >> the chair now recognizes the ranking member of the subcommittee. thank you. in 2006 in my the state of new jersey a 17-year-old honor student named rebecca went to the hospital and within days died from a resistant strain of mrsa. although doctor identified the infection and treated with available antibiotics, it failed to respond to treatment advancing rapidly and cutting her life short. the stores are all to comment on all the more frustrating given the remarkable advances of american medicine. the threat posed by antibiotic resistance bacterial or superbugs is growing as the supply of new antibody drugs is dwindling due to drug manufacturers declining interest and ability to produce new drugs to meet this threat. in the cdc report released last year they find too many americans are infected with antibiotic resistant bacteria each year, and, unfortunately,

23,000 will eventually die of the consequence of their infection. additionally, 5% to 7% of patients in american hospitals will acquire infection during the course of the treatment and though the majority of these infections can be treated, this complicates the recovery process and ultimately imposes greater costs on patients and the health care system. due to the current state of the market, manufacturers are incentivized to focus efforts elsewhere at the expense of r&d with new antibiotics to combat these rapidly evolving strains of bacteria. this reason why congress include many of the provisions of the gain act in today's legislation which was signed into law in 2012, the gain act was an important step for solving this problem. through gain we're supporting manufacturers in the development and introduction of new drugs, largely through the use of marketing exclusivity. so far we've seen meaningful progress because of being committee has approved a number of new drugs, and with priority

review these drugs are able to combat an imminent infectious disease threat and reach patients at an accelerated pace. we should also number by other laws such as the hatch-waxman act is so successful. if congress intervened, we should be sure that it achieves the necessary impact on the pipeline of new drugs to safeguard the public health. in pursuit of the greater good, government struck a balance between the interests of private industry and the public in society reaped the benefits. so that's why i have concerns about ideas such as transferable exclusivity, the practice of giving a specified period of exclusivity to accompany to use of any product it wishes as a report for developing a new antibiotic. this is the recipe for higher cost drugs with no direct connection to the cost of

developing new antibiotics. but there are some ideas worth further examination such as the adapt act introduced by congressman green and gingrey. that would establish a limited population approval pathway that would permit fda to approve drugs based on smaller clinical trials. there are a number of angles the government and private industry can take to make this problem head-on and i think we agree this is an issue which warrants further action and i welcome the opportunity to hear from our witnesses. and a special welcome to adrian thomas from johnson & johnson which is headquartered in my district and i'm always pleased to see you, representative in front of our committee. i would like to yield the remainder of my time to mr. green. >> thank you, ranking member, for yielding. few issues in the public health is as grave and urgent as combatting the antibiotic resistance. yesterday the white house announced the president's executive order, the national combatting antibiotic resistant back terrifia carb strategy.

we need to control bacteria and carbs i district recently both the world health organization and the united kingdom joined the united states and recognizing antibody resistance as a global threat. fighting antibiotics consistent with both the public health at a national security priority. it's a threat i take seriously. the fda has played a central role in this important effort and i think the agency for the work. we must all work together to ensure we have effective antibiotics for the future. in 1929, alexander fleming invented the process for the first antibody wonder drug, penicillin. such discoveries for the 21st century can happen as well if we encourage greater investment to develop new novel antibiotic drugs. antibiotics have saved billions of lives, major therapies like surgery, chemotherapy and care for neonatal infants if possible. by nature bacteria become resistant over time. in addition may choose an inadequate diagnosis contributed to the antibiotic resistance.

most antibiotics are less effective or ineffective against infections. the consequences must not be underestimated. with each day more patients will have few or no therapeutic options because of the resistance available. i thank the chair and ranking member for this hearing today to antibiotic resistant must be a high priority for this committee and central of our way of how we treat and cure disease in the 21st century. i want to thank my colleague congressman gingrey for partnering both on the gain act last congress. >> the chair thanks the the gentleman and recognizes dr. gingrey for five minutes. >> thoonk you for calling today's hearing. within the 21st century cures.

initiative entitled on the antibiotics resistance a new drug development. let me first commend chairman upton and a colleague from colorado for spearheading this bipartisan endeavor that looks at ways we can address emerging challenges in health care industry. i have participated in a number of hearings and roundtable discussions and found each to be very beneficial to all the members of the subcommittee. mr. chairman, we all understand that antibiotic resistant pathogens are a growing concern not only across the country but across the globe. according to the cdc in atlanta, each year more than 2 million americans get infections that are resistant to antibiotics resulting in the death of some 23,000 people, and costing our health care system nearly $20 billion in direct costs, probably $35 billion more in indirect costs, lost time from work, et cetera. this year alone both the world health organization and the uk have acknowledged this looming threat. just yesterday the obama administration took action on

antibiotic resistance as well. through the signed executive order, the national strategy on combating antibiotic resistant bacteria and the president's council of advisors on science and technology, referred to as pcast, and they will be issuing a report. this is an issue that is now receiving global attention. unfortunately, according to the fda new antibiotic approval has decreased by 7% since the mid-'80s. combination including of course the high cost of drug development and the small profit margins have helped drive companies out of the anti-infectious space to markets where return on investment is much higher. you think your favorite drug whether it's for arthritis or whatever, they said they can make a lot more money and there's a lot bigger market. these few incentives for

companies to produce new antibiotics had yielded a stagnant research and development pipeline for antibiotics, and it is ill-equipped to keep up with the evolving bacteria. mr. chairman, i am glad congress has been a true leader in this arena. where t-- with the partnership f my colleague from texas as the other author, sponsor of the gain act, we could find a path for this legislation to be signed into law and it was in july of 2012. as many of the witnesses testimony today, the gain act has been an important step to encourage new development of antibiotics by focusing on economic incentives to keep companies in the game, in the market. however, despite these advances, there's still more work that needs to be done. that's precisely why mr. green and i authored h.r. 3742, the adapt act during this congress. this legislation is a logical next step to the gain act to develop a new pathway at the fda for antibiotics aimed at

treating merging threats and limited and high need populations when they have no available option at their disposal. the adopt act will also streamline the process by which the fda updates breakpoints information so doctors and medical researchers have the most up-to-date information which to expedite decisions in the drug approval process. mr. chairman, the model of the 21st century cures initiative works on the gain act and the adapt act has been a true bipartisan product, and i commend mr. green for his continued efforts with me on both pieces of legislation. earlier this morning both of us spent an hour on "washington journal" discussing our efforts addressing drug-resistant bacteria with a sense of comity, befitting our committee. and i think mr. green as a

moderator and hopefully all the viewers and listeners would agree with that. and with that in mind i look forward to hearing from all of our witnesses today, the first and second panel. i had the pleasure yesterday of meeting with dr. barbara murray who will be on the second panel, the president of infectious diseases society of america, and and at the hearing some of her accounts of life-threatening infections with her own patients. i'm even more motivated to continue the fight against drug-resistant bacteria. i will give a quick anecdote, mr. chairman, i know i'm running out of time but my brother is one year older than me and in 1941 he was sick as a board home with pneumonia and the family doctor came to the house and told my parents, said he was going to die unless they gave him a shot of this new

antibiotic called penicillin. my brother james got that shot of penicillin, and fortunately he lives. there have been some days since then i wish he hadn't. he beat me up every day since then, and still does. but that's my my own little and -- anecdote. mr. chairman, as we continue with 21st century cures initiatives we must work in a bipartisan manner to address this growing problem across the country. ultimately i believe the adapt act is the next step in the fight and it's my hope we will pass this legislation during the lame-duck session later next month. until then i welcome the testimony that we'll be hearing today to further educate members it will raise awareness on this important issue. thank you for allowing me the time normally reserved for chairman upton and i look

forward to continue network with my colleagues as this process moves forward. thank you for the extra time and being a little soft on the gavel, mr. chairman as i yield back. >> chair thanks the gentleman and thanks him for his leadership. now recognizes the ranking member of the full committee mr. waxman for five minutes. >> thank you very much. we have hearings in this committee in 2010 on the problem of antibiotic resistance and the fact that it's a growing and dangerous threat to public health. it certainly is an issue that deserves the full and complete attention of this committee so i'm pleased you're holding this hearing. our overarching goal is to assure people can continue to benefit from these life-saving treatments here in the united states and around the globe. this is a difficult goal to achieve. after all when we use these antibiotics it leads to the

development of pathogens can no longer be treated by those antibiotics. rather than use it or lose it with antibiotics it's use it and lose it. so we're at great risk of losing much of the progress that has been made in fighting infection and subsequent disease. many americans die each year. we pay a high price in other ways as well for hospital stays, moment readmissions, increased doctor visits. all at unnecessarily to the nation's angel health care bill. it will take a multi-pronged approach to overcome this very serious problem. there's no question that our arsenal of effective antibiotics is dangerously low today as a result of antibiotic resistance. so we need to replace

ineffective antibiotics with new ones. in the 2012 fda user the legislation we enacted a law designed to trade incentives to companies to replace those antibiotics and develop new ones. that legislation included provisions from what was called the generating antibiotic incentives now act, called the gain act. and that granted a five year period of exclusive marketing for new antibiotics for serious and life-threatening diseases. i look forward to hearing today from our witnesses about what impact that legislation is having on investments in these drugs, exclusivity, rewards drug companies by allowing them to charge higher prices. as a result it also imposes a significant burden on patients and on the health care system overall. so we need to approach this particular form of incentive

with great caution. one bad idea, in my opinion, is the concept of transferrable market exclusivity, which is sometimes called the wild-card exclusivity. this form of exclusivity would give a company that developed a new antibiotic the ability to transfer a term of exclusivity to another drug. any other drug that they have. this is a hugely costly idea that leads to unfair cross subsidies. if astrazeneca were to develop a specified antibiotic, they could earn a term of exclusivity that it could transfer to nexium, a treatment for heartburn which is the second highest grossing drug last year, and earns over $6 billion. even if the term of exclusivity were just six months, that would

result in a reward of almost $3 billion. that means nexium patients pay higher prices for longer even though they may never actually take the antibiotic itself. as we tackle the problem of antibiotic resistance, we need to ensure that whatever form of the incentive takes, bears some reasonable relationship to the amount of the investment the company is making. i hope we'll discuss today another approach to getting new antibiotics on the market that's referred to as the adapt act. that bill would establish a limited population approval pathway that would permit fda to approve drugs based on smaller clinical trials. this is an idea worth examining. if we do create such a pathway, any drugs approved as a result

would need to be clearly marked with a prominent symbol to alert providers and patients that the safety and effectiveness of these drugs has only been assessed on a limited population, requiring a designati designation. providers have to know these drugs are to be used only when absolutely necessary otherwise not only put patients at risk but will contribute to the more rapid development of anti-microbial resistance of the drugs. in addition to incentives and developing new antibiotics we ought to find ways to cutback on the overuse and misuse of these drugs. patients cannot expect to get them every time they come down with a cold. and physicians should only prescribe them when they are truly necessary. perhaps most importantly, the indiscriminate administration of these drugs in animal

agriculture operations needs to stop. we should mandate an end to this practice. but if we cannot take that step we should at least have a better data, have better data about how and where antibiotics that are important to humans are being used in food animals. we know practically nothing about this situation. as a recent reuters article point out the data exists in the hands of major corporations producing these animals. mr. chairman, another few seconds. like purdue and tysons. i have a bill and i hope it can be included in the 21st century cures legislation. i thank the witnesses for being here today and their testimony. mr. chairman i would like to ask unanimous consent a statement produced by congresswoman louise

slaughter be added to the record. she talks about anti-resistance drugs. >> without objection so order. i have a unanimous consent request. i would like to submit the following for today's hearing record. first a letter from the flag and general officer's network, an official veterans organization representing three quarters of all living u.s. armed force flag and general officers. secondly, a statement from pharmaceuticals, a global pharmaceutical company headquartered in lexington, massachusetts. thirdly, a statement from the california health care institute, the statewide public policy organization representing california's leading biomedical innovators over 275 research universities and private nonprofit institutes, venture capital firms and medical device diagnostic, biotechnology and

pharmaceutical companies. without objection, so ordered. all members written opening statements will be made a part of the record. at this point we have two panels to present testimony. on the first panel today we have, again, dr. janet woodcock, director of the center for drug evaluation and research, u.s. food and drug administration. thank you very much, dr. woodcock for coming. your written testimony will be made a part of the record and you'll be given five minutes to summarize your testimony before questions. so at this point you're recognized for five minutes for opening statement. >> thank you, mr. chairman and members of the committee for holding this hearing on this really important issue. there is broad agreement that anti-microbial resistance is a worldwide crisis that's going to require major efforts combat. in 2012 congress took a significant step in passing gain act, and we have been

implementing it. in europe the innovative medicine initiative has launched a major research effort on anti-microbial resistance. yesterday the administration released a national strategy for combatting anti-microbial resistance. a high level task force was established by executive order to carry out and develop an action plan to carry out the goals. the strategy is a multi-sector effort to attack this problem in all its diverse forms. by bolstering basic research, enhance product development, improving the surveillance, which has been alluded to. resistance and use of microbials, modifying the use of antibiotics in food animals and strengthening international collaboration. pcast which is the president's council of advisors on science

and technology released a scientific report and scientific recommendations yesterday. over the past year the center for drugs at fda has been very busy on this issue. we have issued many new or revised guidances on anti-microbial drug development. we approved three discussion designated under the gain act. we recently co-sponsored a workshop on this topic with the national institutes of health. and, of course, the center for biologics have been working on vaccines another way of addressing this problem and working on testing methods. despite all this progress, we must recognize that at that robust pipeline of new investigational anti-microbials does not currently exist. nor are there large number of drug discovery laboratories out there working to bring forth the next generation of candidate

drugs. so, we don't have a robust pipeline. the reason for this apparently is primarily absence of commercial incentives to anti-microbial development. this problem must be solved one way or another if we're going to prevail in our fight against the ever changing microbes. we don't just need right now which we do need urgently new treatments for resistant organisms although we need it urgently we need to keep introducing new treatments against common conditions as well. since our existing armory will weaken over time so we need to respond the current crisis we need a robust plan going further. we must work together to prevent the loss of these critical weapons against disease. so i'm very happy to answer any

questions. >> i'll recognize myself for five minutes. dr. wood corks yesterday fda commissioner posted a blog post titled fda's take on executive order national strategy combat antibiotic resistance. she wrote few issues are as critical or time urgent as combatting the growing threat of antibiotic resistance. it's a high priority for fda to work with our partners to find solutions for this serious public health problem, end quote. would you explain the urgency of this situation for public health and national security? >> as many members have already stated for public health we're already seeing excess deaths and we're seeing people who, in fact, cannot be treated with any existing therapy that we have. and i think the threat here to

public health is we can have emerging epidemics of these organisms if they will spread. right now they are fairly limited and sporadic but they will spread and we'll be in a situation where we literally can't treat an infection that is unfolding in a wider sense. in addition each year we're seeing greater and greater resistance problems for ordinary microorganisms. so doctors are turning to second or third line anti-microbial agents, agents we used to reserve for very selected situations. and as that occurs more resistance to those will evolve and so eventually we'll be empty handed. >> in the case of antibiotics even slight variations in the bacteria's genetic makeup, can be the difference between a drug working or not working. understanding that back terry all resistance compounds this

problem many times over y-is it important for our antibiotic drug plain that we have multiple drug options for the same class or family of drugs? >> yes. well, what we know when we develop an antimicrobial evolves over time after that antimicrobial is used. and after time it may be that it can be effective against certain forms of an organism and not against other more resistant forms. the mechanism of resistance is different. there are many different mechanisms of resistance. that's why having large number of drugs in a class or even improvements in the class can be extremely helpful in this situation because you can match the antimicrobial to the organize jannism you're trying to treat. >> do we have the type of drug redundancy highlighted above that we need to effectively combat this problem right now? we do not, because it's sort

of the cutoff line, the anti-microbials that are no longer useful against many infections is getting higher and higher every year especially for certain types of bugs. >> do you believe that we need to further incentivize new drugs if we'll address the issue of antibiotic resistance and if so what do you recommend. >> i do believe we have to incentivize it. it doesn't appear that it might not be a loss to business. that there isn't an attractive enough business model to build those robust programs that are needed to both discover and then develop new classes of

anti-microbials. for diagnostics, i will tell you that louie pastuer and alexander fleming would recognize the methods we use today because they invented them. so there's a lot of room at the top for improvement. we're using genetic sequencing of human genome which is huge compared to the microbial genome but used in clinical practice of advanced methods is not the norm and that improving diagnostics. >> could it be used in other unmet need areas than just beyond antibiotics? >> well, of course i believe that that is possible. however, as i think mr. waxman said there are tradeoffs. you have to balance -- there are

always tradeoffs in putting these incentives in place and being a physician and scientist i'm not the most qualified person to make those tradeoffs. i think congress has to weigh those. i can tell you that the urgency, public health urgency for this problem is severe, and will continue and i think you'll hear that from other experts as well. we're not over the hump here. we have not succeeded in developing a system that will continue to generate effective new microbials. we don't have that. we have sort of heroic efforts here and there. >> thank you, dr. woodcock. my time has expired. thank you, mr. chairman. both the executive order issued yesterday in the report of the president's council of advisors on science and technology emphasized the danger of antibiotic using agriculture industry and while it's clear we should do more to encourage

greater research and development of new drugs it also makes sense we should be investing in efforts to limit the further spread of resistant bacteria strains. so, dr. woodcock, in your testimony you point to fda's cooperative effort with cdc to promote greater stewardship including the get smart campaign i want you to elaborate on this role. >> well, obviously, there needs better stewardship both in human use of anti-microbials as already has been said, about half cdc estimates of anti-microbial outpatient prescriptions are not necessary given the condition a patient has and that leads, especially if people only take the drugs for a little bit, kit lead to big problems. and also in the animal world.

now in the human area fda is collaborating with cdc on these efforts but cdc is primarily the lead on improving better use in health care and that's a multi-faceted effort. in the animal health space, fda had put out a guidance, center for preventsive veterinary medicine to cease continued use of important human anti-microbials for growth promotion in food animals and they have secured the cooperation of the, all the manufacturers who are engaged in that space to my understanding and then there's a process whereby those indications are withdrawn and then use in food animals would be required under the sue per vision of a veterinarian. that would be a great

improvement. also as was discussed in the report yesterday, though, we need better surveillance and data to understand the link between anti-microbial use in animals or humans and the development of resistance. that's still rather poorly understood. >> all right. thanks. i wanted to get fda's views on certain aspects of the adapt act. as i understand the purpose of the bill's goal is to facilitate fda's ability to approve new antibiotics that have been tested in a limited population and for which the need for the drug is critical. i know you do approve drugs for limited use like drugs for rare diseases. why they are not meeting the current need and also like you to address whether you believe the adapt act is currently drafted provides fda sufficient authority to ensure adapt anti-microbials will be labelled in a way that distinguishes them as different from other

anti-microbials. it seems if we're considering allowing drugs on the market tested in very limited clinical trials we need to be confident that providers and patients understand the care in which these drugs must be used. >> yes. well, we think the adapt act has elements that we have been discussing for a long time. let me explain some of the situation. we approve drugs for limited population all the time. orphan drugs, rare subsets. but generally speaking the clinical community is not tempted to use those for somebody with a cold. right? it's for some rare enzyme deficiencies or rare cancer. with anti-microbials the big problem really is the use of outside of where it would clinically be indicated, and one of the barriers for these higher resistant organisms is the

occurrence is sporadic. we're very lucky that they are not widespread outbreaks, right. but because they are not widespread outbreaks it means the testing of them in broad populations is difficult. and actually that's good news because otherwise we would really be in trouble, all right, if there were large numbers of people suffering like this. so that means by definition if you're going to get these drugs on the market for these small populations of resistant organisms you have to have small trials and you'll have more uncertainty about the effects. so, more uncertainty about the effects, worry that they will be used in conditions where it's not warranted. those are the two issues we're trying to address. in orphan conditions, yes, there's uncertainty about the effects. but the orphan community that uses these drugs usually those are subspecialists who are treating a very rare disease and have a very good understanding

of what the study was done on the drug and so forth. it often may be the only drug ever studied for that condition. so, our thoughts and we have the administration has not taken a position on this but we have thought about this that to offer very small development programs is a big incentive, but the quid pro quo is to send a signal to the clinical community, you know, some kind of signal, some kind of message that this is special, there's more uncertainty and also really good, use good stewardship about this particular product because using it in a lot of conditions where it's not warranted would also more rapidly increase the development of resistance. >> thank you. >> chair now recognize gentleman from georgia dr. gingrey, five minutes for question. >> mr. chairman, thank you for recognizing me. i know that vice chairman of the

subcommittee, my colleague, burgess was scheduled to go next. thank you for letting me ask my questions now. dr. woodcock, thank you too, as a witness, we had you before our committee many times since i've been on the committee, and you're just always so straightforward and you explain things in a very clear way and i mean that sincerely. you do a great job. and we appreciate that very much. i want to continue in the line of questioning that mr. pallone started, and, again, i have limited time so let me get right into that. congressman green and i have been working on this adapt act, as you know, and it's legislation that supports the fda's selectability to consider all forms of evidence in addition to data from clinical

trials when considering novel antibiotics. how important do you believe adaptive and unique trial designs can play in encouraging new antibiotic drug development? and before you answer that part, just -- i'm sure everybody can hear and probably knows this, but in your typical phase three trials before a drug can get to market, you're going to have to have a population of 1,000 or more people that you're treating. and there are also other requirements that they can't have had an antibiotic within 24 hours of the start of the trial or at one point it was three days, i think and then we got it down to 24 hours. but, you know, you're going to have a limited population of people that have these diseases, and when they get to the

hospital sick as heck, the first thing the doctor is going to do, the administering physician will hang some antibiotic even if it's wrong, they are going to start treating them and then all of a sudden they are not eligible and you have limited number of people. if you wait until you get 1,000 it's too late. so, if you'll kind of take that a step further and discuss that for us. >> thank you. and thank you, mr. green, for your leadership on this. i think it's very important. yes, there is a range and i think that's what people have to recognize. there's a range of development programs that are needed. for common conditions outpatient, pneumonia we have a lot of drugs out there that still work, right. we introduce new drugs we want them to be just as good as the other drugs and they are going to need larger development programs, right and that's true for many. but for these very rare,

fortunately, resistant organisms that are multi-drug-resistant and almost nothing to treat them these cases are occurring sporadically here or there or outbreaks in icus and we have to think of different ways of evaluating new treatment. we can't sit up a trial and wait for this to happen and expect we can enroll thousands of people. and it is true, in fact -- if we enroll thousands of people it would be too late because this would be a terrible thing. so, it is true that all anti-microbial drug development very difficult. in addition the economic problems, there's this huge difficulty in doing trials especially in people who are really sick you can't use a placebo, obviously. you don't know because the problem with diagnostics you may not know for a few days what organism they are infected with. and so there are all these technical problems that make it

very difficult to do anti-microbial drug development. so because we have a tremendous unmet medical need for people, where there's no treatment available, typically what we in case is we have more uncertainty. that means novel trials -- >> i commended the president for this on his executive order of just yesterday. and the $20 million award for the development for this point of care diagnostics. or someone a -- a pill or a piece of tape or something and put it inside their mouth. if it turns a certain color, you know what you're dealing with right there and you don't have to shotgun approach. you can immediately go right to

what you need. i think that's a great -- >> i agree. if we can bring diagnosis of infectious disease into the 21st century, we would have made a huge advance and really accelerated the development of therapy. so that is a good thing. >> thank you very much, mr. chairman. >> i recognize the full committee. fs you've done a wonderful job at fda and your responses to questions from both sides of the aisle have been very, very thoughtful and i want to commend you for the work you've been doing. and thank you for it. i want to echo the comments by mr. pa lone about the comments about strong labelling or logo in the comments of the adapt act. i think it is a prominent statement with the abbreviated

pathway that came to market without this requirement. i'm not sure that -- that the whole thing would work. it would be much less likely to achieve its purpose of fostering and facilitating development of critical new antibiotics for life threatening resistance pathogens. in judicious use of a drug developed through this pathway could result in both patient harm and in more rapid loss of the drug to antibiotic resistance. so i want to undercore that point. i want to ask about a concept that you mentioned in your tempt designed to spur development of new antibiotics. that's delinkage. as i understand it, under this model, the sale of antibiotics would be from the returns of investment. we don't want, say we want more antibiotics sold, we want to make sure that antibiotics that are sold and used are antibiotics that could have stayed effective for as long as

possible. so some other funding mechanism would be created besides the traditional way of selling more drugs to assure a company was able to make a profit from developing an antibiotic. as others have noted the usual pharmaceutical business model doesn't fit very well in the case of antibiotics, we need to however recognize companies need to be able to recoup their investment and make a reasonable profit. and others raise the notion of exclusivity, and i mention that it is a very dangerous idea we don't want to force patients taking one type of drug to fund development of another. so ensuring that raantibiotic developers are linked to a product aep how much is sold seems like a brilliant way to approach the problem. could you elaborate and tell us more about what ideas you have

along the lines? >> well, yes. because right now, we have incentives that actually weigh against our objectives. the objectives is that we have the use of new anti-miebales possible and the inincentive, if you spent $500 million developing the drug, you need to recoup that amount of money and fair prove it to stay in business and develop the next generation. and so these invent ifs are side ways. and they are counter veiling. so that's one idea that's been raised that we mentioned to delink the need to have a large volume of the antibiotic use which would then lead to faster development of resistance. so if that were delinked from the -- >> you have ideas of how do that? >> as i said, i'm not good at financial matters and so -- >> we depend on you for

everything. >> there is pharmaceutical, food and other things that fda does. >> there is an effort to address the antibiotic resistance problem just released report on combatting antibiotic resistance from the president's council of advisors. and it stresses the importance of increasing the longevity of current antibiotics by improving the appropriate use of existing antibiotics an it discusses the need to lock at both human use and animal use of existing antibiotics. we know there is a lot of inappropriate use of antibiotics and both on the human side and i believe on the animal side. the p-cash report explains the role of this type of inappropriate use.

you agree that diagnostics are important for stewartship efforts, and you alluded to this earlier, but can you describe how the widespread diagnostic would help preserve existing antibiotics, as if the fda issist taking any actions to foster the development and use of these tests? >> i believe that diagnosis should be the foundation of therapy. and unfortunately, in the infectious disease space, often you're treating well before you know or before you ever know like what the person has. and this is a fundamental problem. like i believe the add vent of rapid strep testing has really reduced the use of drugs for presumtive strep that often is cold. colds or something. and respiratory infections. so if we could get more certainty into the diagnosis early, be able to reassure the doctor and patient for family, that no, this is not a dreaded

bacterial infection that needs an anti-microbial, we could go a long way, i think, to lowering this inappropriate use. so the dying note of iks and key are just far away from that right now. we need to stimulate that. >> are there more incentives for that? >> i believe so. >> gentlemen now recognizes dr. burgess. five minutes for questioning. >> thank you. again, welcome to our humble little side committee. your last statement, dying note offic nost /* diagnostics are the key. we have had discussions on diagnostics and i realize it is not your part of fda talking about increasing the regulation of testing particularly laboratory diagnostic tests or laboratory development tests rather. but that factors into the

equation and time it takes to get through the pipeline and also if it takes the testing longer to get through the peep line we are actually making things harder on ourselves, are we not? >> yes. we have recently for example we've had a workshop with brookings on this issue of the co-development and technical issues and the final guidance that we put out recently on diagnostics for life threatening disease, we will fill the drug if it is not baked yet. there were g gnome tests that could rapidly change this situation. so i have great hope that this will be coming soon. every disease, cystic fibrosis for example, there are 150 different mutations in that gene.

each of which may to a different feeno type in diagnosis. that goes with cancer and many other diseases. we need to rapidly get to a point where we have a true standard that we can agree upon and so we know what we're dealing with. and we will rapidly improve development of drugs for these serious conditions. >> i share your enthusiasm for g gnomic testing. i seem to remember in my first term on this committee, many, many years ago, talking about some of the same things. and it is sort of like the flying car. we're still waiting for that to happen. on the issue and at hhs, you did your study on the antibiotic initiatives and development for new drugs, vaccines and rapid diagnostics for bacterial

diseases. and talked about moving the needle in monetary terms for companies by a reduction of the time for clinical trials. correct? >> yes. >> is it really possible to move the needle on that? >> well, i believe for the, say the limited population antibiotic development use, that is possible. that's only one factor. but if you have a very high bar getting on the market then you need much stronger incentives for, i believe, for those very rare resistant organisms, we could have very small development programs and that there is societal agreement that having a treatment available for those is better than having nothing. so we could have strong development programs. we could say to the clinical community no that this is different. no that this didn't is a huge development ra